Pharma Senior Quality Officer – Clonmel
Als Life Sciences
Clonmel, Tipperary
About the Position. ALS are in the final stages of fitting out a new Pharmaceutical Chemistry building in Clonmel to add to the current Pharmaceutical Microbiology offering in Clonmel. This role is a genuine career opportunity for someone looking to enhance their career prospects and to join a market-leading company with highly ambitious growth plans in Ireland. Reporting to the Laboratory Management team on site, you will support them to manage and monitor all laboratory aspects of Quality within the Chemistry and Microbiology departments on a day to day basis at the ALS Pharmaceutical Laboratories located in Clonmel, Co. Tipperary. This position is a permanent position and will be based at Clonmel following an initial training period at the ALS Pharma laboratories in Ely, England. Responsibilities. Co-ordinate and lead activities to close-out corrective/preventive actions arising from anomalies, complaints, OOS and laboratory investigations, internal and external audits (including INAB, HPRA and clients) within agreed timelines as per ALS Group procedures. Support the Laboratory Team in management of equipment and equipment records ensuring that all items of equipment are correctly recorded, labelled and are calibrated at the appropriate frequency in accordance with the site calibration/service schedule. Take ownership of the Pharma change control procedure, ensuring that assigned tasks are completed to the scheduled timelines. Management of the CAPA process within the Pharma Laboratory. Ensure that all methods and procedures held by the laboratories are current and that there is documented evidence that all relevant staff are trained accordingly in current and revised procedures upon re-issue as per the group document control process. Regularly update trending systems for Right First Time (RFT) data generated by the laboratory. Support the Laboratory Team to ensure that training records are maintained in line with ALS Group procedures. Support the Laboratory Team in management of External and Internal Quality Control samples including maintenance of the in-house IQC reference material. Assist the Laboratory Team during customer and regulatory visits/audits. Control and archiving of laboratory records in accordance with ALS Group procedures. Support the Laboratory Team to ensure that all relevant Health and Safety information is included on Client provided methods. Ensure all Quality requirements are met and delivered on time and review procedures and systems regularly for continuous improvement. To provide the Laboratory Team with updates and reports upon request. Lead Pharma laboratory routine audit trail reviews and prepare reports in line with current regulatory requirements. About you. The minimum requirements for this position are; A scientific background (degree level) where analytical skills can be used for problem solving. An understanding of Quality Management Systems, INAB/UKAS and GMP requirements and the knowledge to drive change within the Pharma Laboratory. 4 years experience working in a GMP environment. The ability to work on your own and manage projects to tight deadlines. Excellent communication and interpersonal skills. Ability to influence opinion and set standards. Understanding of the Pharmaceutical Industry and clients’ needs. Good computer literacy skills. High level of reporting and writing skills. Excellent organisational skills and the ability to multi-task. High attention to detail and a methodical approach. To be successful in this role you will have experience in a significant number of the following areas: CAPA system management. Change Control. OOS investigations. Laboratory investigations. Regulatory audits. Laboratory Health and Safety. This is an excellent opportunity for a motivated and skilled person looking to develop their career with an international company. Attractive remuneration and benefits available with future increases dependant on performance . This job originally appeared on RecruitIreland.com.
1922 days ago